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Setting the stage: Privacy, security, regulation, and

voluntary data sharing within Precision Medicine

UCSF Mini-Medical SchoolNovember 7, 2013

Claire D. Brindis, Dr. P.H.Director, Philip R. Lee Institute

for Health Policy StudiesProfessor, Pediatrics and

Health Policy

Precision Medicine and Personalized Medicine

Genome

Metabolome

Microbiome

Environment

Epidemiology

Patient Medical Record (experience, behavior, etc.)

Proteome

Building a layered knowledge network: Interlayer connections established by multidisciplinary teams

•

UCSF Precision Medicine Platform

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UCSF Precision Medicine Platform

Regulatory

Privacy

Data Sharing

Security

Consumer Engagement

Ability to Integrate practices and policies across three planesAbility to Integrate practices and policies across three planes

Biomedical continuum:Build seamless links between basic discovery, translation, clinical care, patients, citizens

Biomedical continuum:Build seamless links between basic discovery, translation, clinical care, patients, citizens

Transdisciplinary science:Merge physics/chemistry/engineering/Computation theory, concepts, methods into biomedical research

Transdisciplinary science:Merge physics/chemistry/engineering/Computation theory, concepts, methods into biomedical research

Stakeholder synergy:Cooperate across .edu, .com, .org and .gov sectors and others Stakeholders

Stakeholder synergy:Cooperate across .edu, .com, .org and .gov sectors and others Stakeholders

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EMRs, diagnostic images Claims, revenue cycle

Clinical trials, genomics Purchasing patterns, social media

Geo-environmental, weather patterns, etc.

Table of Contents

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变

Chinese Symbol for Change

变

Danger and Opportunity

From here to tomorrow: The Promise of Precision Medicine

What system infrastructure will be necessary?

What health care systems will need to be in place to provide precision and personalized medicine?

Along the continuum of health and illness, how could precision medicine be integrated?

What will it take to create such a system?

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Challenges in Implementation ofPrecision Medicine

1.

1. Capacity to interpret genomic sequence data?

What genetic variants are ready for “translation with impact” on sufficiently large proportion of population?

Derive new insights from complex and large data sets.

Challenges in Implementation ofPrecision Medicine

2. “$1,000 genome” -- Sequencing an individual’s or a tumor’s entire genome can occur relatively inexpensively and can be offered as part of clinical care.

Downstream interpretation will likely add significant costs (at least in the short term).

Challenges in Implementation ofPrecision Medicine

3. Are technological advances outpacing our ability to use information effectively?

4. Are we as a society ready to make these types of investments? Disparities?

Challenges in Implementation ofPrecision Medicine

5. Regulatory issues - Examples

FDA Drug Approval

Linking data from patient care with data from research.

Precision Medicine needs to have identifiable data vs. basic and translational research use de-identified or unidentifiable data.

Institutional Review Board requirements

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Challenges in Implementation ofPrecision Medicine

6. Determining Coverage and Reimbursement –

-- Molecular testing codes

-- Reimbursement concerns for patients

-- Unclear value for payers

Challenges in Implementation ofPrecision Medicine

7. Patient Confidentiality and Consent

Learning From the Past…..Challenges in Implementation of

Precision Medicine

8. System Capacity

• Maintaining confidentiality and protection of data

• Standardized risk assessment tools

• Integration of family health history into EMR

• Develop capabilities (consent, interpretation, counseling) for solving diagnostic dilemmas

• Developing clinical decision support tools for pharmacogenomics and diagnostic tests

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Challenges in Implementation ofPrecision Medicine

8. System Capacity (more….

• Develop the policy agenda to support PPM

• Assess genomic medicine literacy of patients and providers

• Education for the next generation of providers and health care workforce

• Active engagement of patients and their families

Challenges in Implementation of Precision Medicine –9. Intersection with Population Health?

Value

In the meantime…. Forecasting

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Prediction is always difficult, especially about the future

Niels Bohr

Ginsburg GS and Willard HGenomic and Personalized Medicine. Academic Press: 2012.

Time

Co

st

Baseline Risk

Preclinical Progression

Clinical Diseaseand Progression

Dis

ease

Bu

rden

TreatmentPrognosisDiagnosisSusceptibility Screening

The Opportunity for Genome Informed Medical Care

Personal data value chain

LabelLabelLabel DisseminationProcessing and analysisStorageData CollectionEstablish

Compatibility

The individual

• Storage protections may be different

• Storage location could be in different sovereign states

• Storage period can vary from original intent

• Personal data could be collected from the individual in either a passive or active manner

• Collection of data may be transferred to multiple stakeholders

• Purpose of analysis could change from originally stated purpose

* Intent of analysis and degree of anonymization) could change

• Dissemination could include transfer to different entities or types of entities

• Levels of protection and protection capacity can vary between parties

• Different purpose/use/ level of analysis

Questions in establishing a personal data value chain

LabelLabelLabel

• Who is the collecting party?

• What type of entity are they?

• What is the purpose for which they are collecting data?

• What type and format is the data?

• Where is the data being stored?

• What policies are in place in the storage location

• For how long?

• What are the protection methods (including technical and organizational?

• How is the data being processed?

• At what level of analysis?

• In combination with what other data sets?

• For what purpose?

• For whose benefit?

• Who is the data being shared with?

• Is it a different organization or entity?

• For what purpose?

• In what location?

• What security mechanisms govern the transfer?

DisseminationProcessing and analysisStorageCollection

Establish Compatibility

Illustrative question set

The individual